Department: Azzur Princeton, LLC
We at Azzur Group are looking for an experienced Sr. CSV Specialist to join our Azzur Consulting: Princeton team.
Do What You Love
At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:
Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!
- Function as the computer systems validation subject matter lead for specific CSV related projects that require quality assurance, and CSV regulatory / GxP expertise.
- Develop and/or provide input to all CSV related life cycle deliverables.
- Perform testing of the entire SDLC, including version/change control and new software rollouts.
- Provide guidance to CSV teams, including but not limited to: 21 CFR Part 11, risk-based approach to computer systems validation (e.g. GAMP5), data integrity, and computer systems assurance.
- BS in Engineering, Science or equivalent technical degree.
- Minimum 7 years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
- Strong working knowledge of FDA and cGMP regulations and documentation practices.
- Proficient in Microsoft Word, Excel, PowerPoint.
- Excellent written and verbal communication skills; excellent technical writing skills.
- Strong interpersonal skills and the ability to work in a team environment.
- Ability to work effectively in a fast paced multitasking environment.
- Advanced degree or industry certifications
- Led CSV project teams
- experience with MasterControl, Valgenesis, ProCal and LIMS